Hansa Biopharma AB announced its decision to initiate a pivotal Phase 3 clinical study of imlifidase to treat anti-GBM disease, following a successful pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA). The recently completed investigator-initiated Phase 2 study by Professor M?rten Segelmark (GOOD-IDES-01 ClinicalTrials.gov Identifier: NCT03157037) showed that two thirds (67%) of patients (10 out of 15 patients) achieved dialysis independence at six months after imlifidase treatment. As a comparison the overall renal survival over 12 trials has been reported to be 26% with current Standard of Care (SoC). This positive outcome served as Proof of Concept (PoC) for the potential of imlifidase to treat IgG-mediated serious autoimmune diseases. Through the pre-IND meeting with the FDA, advice was sought on the design of a pivotal Phase 3 study. The FDA generally indicated alignment with Hansa's proposed study design, including proposed primary and secondary endpoints and intended patient population. Hansa will now submit an IND for anti-GBM disease prior to initiation of the Phase 3 trial and expects additional feedback and input from the FDA. Hansa has also initiated an advice procedure with the European Medicines Agency (EMA) on the regulatory path forward for anti-GBM disease in Europe. The planned pivotal Phase 3 clinical study is expected to enroll approximately 50 patients with anti-GBM disease across the U.S. and Europe and is expected to enroll the first patient in 2022. Patients in this study will be randomised 1:1 to receive either SoC or imlifidase plus SoC. The planned primary endpoint of the study is renal function by means of eGFR at six months. Patients will also be evaluated for other parameters related to kidney function during a six months follow up period.